NCT03711890

Ultra-High Resolution Optical Coherence Tomography in Detecting Micrometer Sized Early Stage Pancreatic Cancer in Participants With Pancreatic Cancer

Imaging and Detection of Micrometer Sized Early Stage Pancreatic Cancer by Using Endoscopic Ultra-High Resolution Optical Coherence Tomography (OCT) Using Resected Pancreatic Specimen, a Pilot Study

• Status: Suspended
• Phase: N/A
• Study type: Interventional
• Enrollment: 75 (estimated)
• Sponsor: Ohio State University Comprehensive Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This trial studies how well ultra-high resolution optical coherence tomography works in detecting micrometer sized early stage pancreatic cancer in participants with pancreatic cancer. Ultra-high resolution optical coherence tomography may help to accurately identify pancreatic cancer in resected pancreatic specimens.

Detailed description

PRIMARY OBJECTIVES: I. To evaluate the using of optical coherence tomography (OCT) to diagnose pancreatic cancer arising in the setting of intraductal papillary mucinous neoplasms (IPMN) using the resected pancreatic specimen. II. To correlate OCT imaging diagnosis with histologic findings in the human pancreatic duct. IPMN is a premalignant lesions arising in the pancreas. Typically, IPMNs are identified incidentally on imaging performed for other reason or related to vague abdominal pain or gastrointestinal complaints. In terms of IPMN, invasive cancer can be found in this setting between 20 to 50% of the time\[7\] Therefore, if a patient is diagnosed with IPMN, especially main duct type, the general recommendation is to undergo resection. We propose to assess the duct of the pancreatic specimen after resection to identify evidence of invasive malignancy by OCT imaging. Afterwards, the specimen will be undergoing histopathologic assessment using standard protocols. Our hypothesis is that OCT will accurately identify pancreatic cancer in resected pancreatic specimen. The assessment with OCT is non-invasive and will not harm to change the specimen prior to going to pathology for standard review. Future studies will then focus on using this imaging technique in vivo to endoscopically identify early stage pancreatic cancer.

Conditions

• Pancreatic Carcinoma
• Pancreatic Intraductal Papillary Mucinous Neoplasm, Pancreatobiliary-Type

Interventions

Type	Name	Description
PROCEDURE	Optical Coherence Tomography	Undergo OCT
PROCEDURE	Therapeutic Conventional Surgery	Undergo resection will be undertaken
DIAGNOSTIC_TEST	Laboratory Evaluation	Labs will be obtained to test for cancer cell derived exosomes

Timeline

• Start date: 2019-03-26
• Primary completion: 2025-12-31
• Completion: 2025-12-31
• First posted: 2018-10-19
• Last updated: 2025-03-30

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study